Trial · NCT02143479
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®) | At baseline | Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg |
| Primary | Time of the first tacrolimus trough level (C0) after conversion | From baseline to first determination of C0 (up to 6 months) | Number of days between the conversion date and the date of the first determination of C0 after conversion |
| Primary | Number of additional visits considered by the physicians to be due to the conversion (if required) | At 6 months and at 1 year follow-up visit | Percentage of patients with additional visit(s) and percentage of patients without an additional visit |
| Secondary | Reasons for conversion | At baseline | Number of pills, number of treatment intake, treatment compliance, physician request, patient request, safety of treatment, center practice |
| Secondary | Patient profile | At baseline | Sociodemographic data, history of transplantation, comorbidities, complications after transplantation, risk factors, concomitant treatments (other than immunosuppressive protocols) and modification, if required, at 6 months and 1 year after conversion |
| Secondary | Collection of immunosuppressive protocol details | At baseline, 6 months and 1 year follow-up visit | * Date of initiation of treatment with Advagraf® * Target tacrolimus C0 (with Prograf® and with Advagraf® and recommendations for administration) * Daily dose of Advagraf® * Adjustments to Advagraf® dose since the previous visit: date, doses and reason for adjustment * Type and dose of immunosuppressive drugs combined with Advagraf® * Modification of the immunosuppressive regimen at 6 months and 1 year after conversion (if applicable) since the previous visit: date, modified treatment, type of modification, reason for modification * Immunosuppressive regimen at the end of the visit at 6 months and 1 year after conversion, modified treatment, type of modification, reason for modification |
| Secondary | Time to reach steady state | From baseline to first determination of C0 (up to 6 months) | |
| Secondary | Dose ratio at steady state | From baseline and up to 6 months post-conversion | Ratio of daily dose of tacrolimus during achievement of steady state: mg Prograf® at conversion/mg Advagraf® during achievement of steady state. Percentage of patients with a ratio of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg |
| Secondary | The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ® | At baseline (Prograf) and during the 45 days after conversion (Advagraf) | |
| Secondary | Latest available laboratory data with Prograf® before conversion and with Advagraf® | At baseline, 6 months and 1 year follow-up visit | Values and dates for renal parameters, liver parameters, blood glucose and Hepatitis C viral load |
| Secondary | Compliance with treatment at conversion | At baseline and at 1 year after conversion | Compliance with treatment at conversion (with Prograf® and only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the Morisky questionnaire and a score will be calculated |
| Secondary | Patients' quality of life at conversion | At baseline and at 1 year after conversion | Patients' quality of life at conversion (with Prograf® only in group 2) and at 1 year after conversion (with Advagraf® for both groups) will be assessed using the European Quality of Life-5 Dimensions 5 level (EQ5D-5L) questionnaire |
| Secondary | Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate | 6 months and 1 year | Will be assessed on the basis of the number of acute rejections confirmed by biopsy and recorded adverse events and adverse reactions |
| Secondary | Occurrence of adverse events and/or effects | From baseline until 1 year follow-up visit |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02143479/registered